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目的:建立新型有效组份制剂红鹤胶囊多指标成分体外溶出度的测定方法并评价其溶出度。方法:依据2010年版《中华人民共和国药典》,以900 m L的0.3%十二烷基硫酸钠溶液为溶出介质,采用桨法测定,转速为100 r/min,温度为(37±0.5)℃。实验以竹节参皂苷Ⅳa、总皂苷、总黄酮为检测指标,分别采用高效液相法和紫外分光光度法检测红鹤胶囊中竹节参皂苷Ⅳa、总皂苷和总黄酮的溶出含量。结果:红鹤胶囊的三批样品,在溶出时间为45 min时,竹节参皂苷Ⅳa的累积溶出率分别为91.29%、88.64%、91.72%;总皂苷的累积溶出率分别为89.41%、87.68%、87.10%;总黄酮的累积溶出率分别为91.02%、90.77%、89.98%。结论:经过溶出条件的系统筛选后所建立的溶出度测定方法稳定,结果可靠。红鹤胶囊中各指标性成分溶出度均符合药典规定。
OBJECTIVE: To establish a new method for the determination of the dissolution of multi-index components of Honghe Capsule, an effective component of the preparation, and to evaluate its dissolution rate. Methods: According to the 2010 edition of “The Pharmacopoeia of the People’s Republic of China”, 900 mL sodium 0.3% sodium dodecyl sulfate solution was used as the dissolution medium and the paddle method was used. The rotation speed was 100 r / min and the temperature was 37 ± 0.5 ℃ . In the experiment, the indexes of bamboo ginsenoside Ⅳa, total saponin and total flavonoids were tested, and the elution contents of sanshinone Ⅳa, total saponin and total flavonoids in Honghe capsules were detected by HPLC and UV spectrophotometry respectively. Results: The cumulative dissolution rate of ginsenoside Ⅳa was 91.29%, 88.64% and 91.72% respectively in three batches of samples of Honghe Capsule at 45 min dissolution time. The cumulative dissolution rates of total saponins were 89.41% and 87.68 % And 87.10% respectively. The cumulative dissolution rates of total flavonoids were 91.02%, 90.77% and 89.98%, respectively. CONCLUSION: The method of dissolution established after systematic screening of dissolution conditions is stable and reliable. Red Crane capsule in the dissolution of the index of the ingredients are in line with Pharmacopoeia regulations.